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Inactive Poliovirus Vaccine

Phase 3

Poliomyelitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 29, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

Inactive Poliovirus Vaccine · 1 trial · 2 indications

Phase 3 1
NCT01389687Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in JapanPoliomyelitis
COMPLETED74 Analytics
PHASE3COMPLETED
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Poliomyelitis
NCT0138968774
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Study Endpoints

Primary Endpoints

A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
1 month post-vaccination 3

Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

Secondary Endpoints

Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination.
Day 0 and 1 month post-vaccination
Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV
Day 0 up to 12 months post-vaccination
Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination.
1 month post-booster vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study GroupEXPERIMENTAL -

Interventions

NameTypeDescription
Inactive Poliovirus VaccineBIOLOGICAL0.5 mL, Subcutaneous
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Eligibility Criteria

Age Range3 Months to 68 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: * Fever ≥ 37.5°C (a...

Countries:Japan
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